Regulatory News

Regulatory publications or updates of recommendations, guidelines and reports affecting research in the 3Rs.

Report from FSVO 3R Symposium on alternatives to CO2 in euthanasia published

Carbon dioxide has long been considered one of the better methods for euthanizing laboratory rodents because it is easy to use, inexpensive, and environmentally friendly. Research increasingly has shown that this gas can be aversive to rodents and that it may be inhumane to expose them to this gas while they are conscious. Therefore, the Swiss Federal Food Safety and Veterinary Office (FSVO) has set out to find a more suitable replacement.  In 2018, FSVO organised a meeting with representatives and experts of the different stakeholders involved in this process in order to find a solution. The experts concluded that it is necessary to replace CO2 in euthanasia. The next step will be to draft a research strategy to find the most suitable replacement. Abstract about the meeting: https://www.mdpi.com/2076-2615/9/8/482

EPA aims to phase out chemical safety tests on mammals in U.S. by 2035

The U.S. Environmental Protection Agency (EPA) announced in September that it wants to undertake efforts to reduce animal testing for chemical safety. EPA aims to reduce study requests and funding of research using mammals by 30% by 2025 with the goal of eliminating them for good by 2035. The government agency also will support five universities with USD4.25 million worth of funding to develop alternative test methods and strategies that reduce, refine and replace tests using vertebrate animals. EPA will finance the development of in vitro models to test for developmental and reproductive toxicants, neurotoxins, and toxicity of complex environmental mixtures.
Press release: https://www.epa.gov/newsreleases/administrator-wheeler-signs-memo-reduce-animal-testing-awards-425-million-advance


German commission publishes guidelines on animal experimentation in research

Germany’s Permanent Senate Commission on Animal Protection and Experimentation published guidelines on animal experimentation to support researchers with the ethical challenges they are facing when they balance the value of scientific progress and animal welfare. The document with the title Animal Experimentation in Research – The 3Rs Principle and the Validity of Scientific Research identify specific requirements for conducting animal experiments in research, and offer assistance on how to ensure validity when planning and describing animal experimental research to ensure both the highest scientific quality and high animal welfare standards.

More information: https://www.dfg.de/en/dfg_profile/statutory_bodies/senate/animal_protection/index.html

FELASA, ESLAV, ECLAM publish position paper on ban of CO2 for rodent euthanasia

The Federation of European Laboratory Animal Science Associations (Felasa), the European Society of Laboratory Animal Veterinarians (ESLAV) and the European College of Laboratory Animal Medicine (ECLAM) published a position paper on the proposed ban of CO2 for rodent euthanasia. They are against a ban until there is enough scientific evidence about the use of carbon dioxide and relevant alternatives and updated euthanasia guidelines by the American Veterinary Medical Association (AVMA) are considered. They urge governments to actively support research initiatives in the field of laboratory animal euthanasia. Euthanasia should only be carried out by trained personnel, using appropriate techniques and equipment, the organisations state in their paper.

More information: https://naturalsciences.ch/service/publications/116958-position-paper-on-the-proposed-ban-of-carbon-dioxide-for-rodent-euthanasia

Animal registries have been slow to be established and used

Millions of mice and rats are used in research around the world each year. But one-third to one-half of animal experiments are never published, and of those that are, many are too poorly conducted to be reliable, according to an article in Nature. Advocates for better animal research and reproducibility are promoting study registries to counter publication bias, improve investigations and increase transparency. Registries such as clinicaltrials.gov for human trials require researchers to detail their hypotheses, experimental strategy and analytical plans before they start their research. The intention is to prevent teams from simply cherry-picking significant or desirable findings and to supply the scientific community with a way of learning about experiments that would otherwise go unpublished. For animal research the University Medical Center Utrecht is offering preclinicaltrials.eu and Germany’s centre for the protection of laboratory animals Bf3R established animalstudyregistry.org, but researchers have been slow to register their studies on these platforms.

Article in Nature: https://www.nature.com/articles/d41586-019-02676-4

Eawag researchers receive ISO certification for non-animal water toxicity test

Environmental toxicology specialists at the Federal Institute of Aquatic Science and Technology (Eawag) have received international certification for a non-animal test used to determine acute toxicity of water samples and chemicals to fish. According to Eawag this is the first time a toxicity test with cultured gill cell lines from fish has been ISO-certified. There still is a lack of recognised alternatives to experiments with live fish. In 2017, researchers in Switzerland carried out more than 7,500 ecotoxicological tests with the aim of protecting humans, animals and the environment. Eawag has been researching alternatives to reduce or replace fish experiments. One of these alternatives involves experiments with a gill cell line of rainbow trout (RTgill W1 cell line). The test saves time, is cost-effective and does not require any laboratory animals. More info:
https://www.eawag.ch/en/news-agenda/news-portal/news-detail/news/statt-tierversuche-fischzellentest-international-zertifiziert/

EURL ECVAM publishes 2018 Status Report on progress made in replacement

The European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) published its 2018 status report where it provides updates on the progress made in the development, validation and regulatory acceptance and use of alternative methods and approaches and their dissemination. The status report describes research, development and validation activities, as well as on initiatives that promote the regulatory and international adoption and use of alternative approaches and their dissemination. More info:
https://ec.europa.eu/jrc/en/publication/eur-scientific-and-technical-research-reports/eurl-ecvam-status-report-development-validation-and-regulatory-acceptance-alternative-3

EFSA publishes guidance on how to communicate scientific uncertainty

Different audiences can better understand scientific uncertainties when expressions and communications formats are tailored to their needs. The European Food and Safety Authority’s new and targeted approach to uncertainty communication will help communicators to further boost the transparency of its scientific advice. The communication approach aims to increase understanding of how scientific experts express their confidence in the methods and underlying scientific evidence used in their assessments, and in their conclusions about potential risks. More info: www.efsa.europa.eu/en/press/news/190116

EDQM welcomes WHO recommendation to end innocuity test in vaccines, biologicals

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has welcomed the recommendation of the WHO Expert Committee on Biological Standardization (ECBS) to omit the abnormal toxicity test (also called the innocuity test) in all future WHO documents on vaccines and other biological products, and to disregard the inclusion of this test in previously published WHO Technical Report Series documents. The ECBS bases its recommendations on the consideration that the omission of the abnormal toxicity test would not compromise the quality and safety of vaccines and other biological products. Animal tests such as the abnormal toxicity test were developed for the safety testing of human vaccines at a time when limited scientific knowledge for the quality control of biological products existed. Over the past decades, researchers have identified viable alternatives, and current manufacturing processes, including the Good Manufacturing Practices (GMP) and in-process quality controls, can ensure a more appropriate level of quality and safety for vaccines and other biological products than the abnormal toxicity test. More info: www.edqm.eu/sites/default/files/press_release_edqm_welcomes_recommendation_on_innocuity_test_november_2018.pdf

Updated Guidance for the testing of cosmetics ingredients and their safety evaluation

The updated notes of guidance from the Scientific Committee on Consumer Safety (SCC) has published. In this 10th revision, the state-of-the-art with respect to the validated methods of the 3Rs (Refinement, Reduction and Replacement) strategy of Russell et al. (1959), is incorporated with emphasis on New Approach Methodologies (NAMs). In view of the testing and marketing bans in the cosmetic regulation, the SCCS gives special attention to those alternative methods that are suitable for the safety testing of cosmetic substances. More info: https://ec.europa.eu/health/sites/health/files/scientific_committees/consumer_safety/docs/sccs_o_224.pdf